NCT00548743

Brief Summary

This is a study to assess the impact of introducing screening and planned follow up for postpartum depression. All women ages 18 to 45 who speak English or Spanish who come to the enrolled community family medicine offices will either be given usual care or screened using the Edinburgh Postnatal Depression Screening tool. If the EDPS score is high the women will be given the PHQ-9 to more clearly identify the specific likelihood of being depressed. Women who are determined to be depressed will be treated with medication or counseling based on the preference of the women and their physicians. Women will be followed through nurse initiated phone calls and visits to the physicians office. Outcomes include the level of depression symptoms, measure of comfort with parenting, and satisfaction with partner relationships comparing baseline levels with those at 6 and 12 months from the usual care and intervention sites. These data will be collected by questionnaire. In addition, with the women's permission, medical records will be reviewed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 4, 2007

Status Verified

October 1, 2007

First QC Date

October 22, 2007

Last Update Submit

December 3, 2007

Conditions

Keywords

DepressionPostpartumDyad satisfactionParenting comfortScreeningManagementFollow upPrimary carePractice based research

Outcome Measures

Primary Outcomes (1)

  • Level of depressive symptoms and level of parenting comfort

    12 months postpartum

Secondary Outcomes (1)

  • Percent eligible women screened and of those screen positive, percent treated and followed according to protocol

    12 months for each women

Study Arms (2)

1

EXPERIMENTAL

Intervention arm

Behavioral: Screening and follow up

2

PLACEBO COMPARATOR

Usual care

Behavioral: Usual care

Interventions

Two stage screening with EPDS and PHQ-9, treatment for depression at physician's discretion and follow up phone calls and visits

1
Usual careBEHAVIORAL

usual care for identification and management of postpartum depression

2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 12 weeks postpartum
  • Able to speak and read English or Spanish
  • to 45 years of age

You may not qualify if:

  • Significant cognitive impairment and unable to answer screening questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olmsted Medical Center

Rochester, Minnesota, 55904, United States

RECRUITING

MeSH Terms

Conditions

Depression, PostpartumDepression

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Barbara P Yawn, MD MSc

    Olmsted Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara P Yawn, MD MSc

CONTACT

Susan M Bertram, RN MSN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 24, 2007

Study Start

September 1, 2005

Study Completion

August 1, 2010

Last Updated

December 4, 2007

Record last verified: 2007-10

Locations